Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA “resulted in clear guidance on the regulatory requirements” for development of the company’s RLS103 dry powder cannabidiol (CBD) for the treatment of panic attacks. The company is pursuing the 505(b)(2) pathway for approval of RLS103.
In 2016, MannKind Corporation announced that it had licensed its Technosphere dry powder technology to the newly formed RLS for use with its products. In 2018, RLS announced that it had raised $29 million in Series A financing for development of its cannabinoid DPIs.
RLS Chief Scientific Officer Andrea Leone-Bay commented, “Alignment on a clear 505(b)(2) development pathway for RLS103 is a significant milestone for the company. Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be first-in-class. We look forward to continuing our dialogue with the FDA and have initiated our IND-enabling studies.”
Read the Receptor Life Sciences press release.
